17. Female subjects with reproductive potential must agree to practice medically acceptable form of birth control during the study • Medically acceptable forms of birth control that may be used by the subject and/or his/her partner include: o Established use of hormonal methods of contraception (oral, injected, implanted, patch or vaginal ring) Barrier methods of contraception with spermicide: condom or occlusive cap (diaphragm or cervical/Vault caps) with a spermicidal foam/gel/film/cream or suppository; o Intrauterine divide (IUD) or intrauterine system (IUS); o Surgical sterilization (vasectomy, tubal occlusion, bilateral salpingectomy); Abstinence from heterosexual intercourse; when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are NOT acceptable methods of contraception